Diagam

Address:Parc Eurasante,LOOS Hauts-de-France,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Alpha-2-Macroglobulin, Antigen, Antiserum, Control (DEB) (2) Calibrator, Primary (JIS) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Yes

Clear

Alpha2-Macroglobulin - 05415168003476 Catalog Number : 08240396190

Device Description : Quantitative determination of Alpha2-Macroglobulin in human serum and heparinise

Device Class : 2

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : DEB

Prescription Use : Yes

Device Count : 1

Alpha2-Macroglobulin Serum CONT KIT - 05415168004763 Catalog Number : 08240426190

Device Description : Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems.

Device Class : 1

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Alpha2-Macroglobulin CAL KIT - 05415168004770 Catalog Number : 08240400190

Device Description : Calibration of Alpha2-Macroglobulin assay on cobas c501/502 systems.

Device Class : 2

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : JIS

Prescription Use : Yes

Device Count : 1

Alpha2-macroglobulin - 05415168006873 Catalog Number : 09029524190

Device Description : In vitro diagnostic reagent for the quantitative determination of alpha2macroglo

Device Class : 2

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : DEB

Prescription Use : Yes

Device Count : 1

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